The outbreak of new coronary pneumonia abroad continues to increase the demand for anti-epidemic materials such as masks. Due to different national standards, my country's exports of non-medical masks are sometimes mistaken for medical use. On March 31, the Ministry of Commerce in conjunction with the General Administration of Customs and the Food and Drug Administration issued the 'Announcement on the Orderly Export of Medical Materials' (No. 5 of 2020), requiring that the export of medical masks and other five types of products must obtain relevant information from the national drug regulatory authority. Qualification, in line with the quality standards of the importing country (region). So, how do you quickly and accurately distinguish between medical and non-medical masks? Please come to understand with the release. 1 The basic classification and subdivision of masks. Masks can be divided into two categories: medical and non-medical. As the name suggests, medical masks are mainly used for medical protection, which can be subdivided into three types: medical protection, medical surgery, and disposable medical; non-medical masks are also called personal protective masks, which can be subdivided into protection according to their application scenarios. Both particulate matter and daily protection. Masks for different purposes have different technical requirements and different scopes of application. China's main mask classification 2 uses appearance and packaging information to distinguish medical/non-medical masks by mask structure and filter valves. Masks with filter valves are generally not medical masks. For example, Article 4.3 of the Chinese Standard for Medical Protective Masks GB 19803-2010 clearly stipulates that “masks should not have an exhalation valve”, which can prevent droplets and microorganisms from exhaling through the exhalation valve, thereby harming others. Civil masks are allowed to have an exhalation valve, and the exhalation resistance can be reduced through the exhalation valve, thereby facilitating long-term work of the operator. The smallest unit package of copper mask
products sold through formal channels should be distinguished by the information on the outer packaging. There should be information such as the name of the product, the implemented standard and the protection level. The information expressed by these businesses can be used as a distinguishing point. For example, if the product name contains words such as 'medical' or 'surgical' or 'Medical' in English, it can generally be judged as a medical mask. 3 Applicable standards to distinguish between medical and non-medical masks Medical masks are applicable to different standards and certification requirements in different countries/regions. Enterprises and individuals can distinguish according to the country/region where the product is imported and the applicable standards of the product. The applicable standards and certification information of the product can be distinguished. Obtained from the outer packaging of the product or the test report or certificate provided by the manufacturer. Medical masks exported to the U.S. are medical devices in the U.S. They are subject to 'Standard Specification for Medical Material Performance' (ASTM F2100) and are managed by the U.S. Food and Drug Administration (FDA). They must be registered through 501K or other channels announced by the FDA recently to obtain factories Only after registration and listing of the medical device can it be listed in the United States. Therefore, masks exported to the United States on the outer packaging or test reports or certificates with the above content can be judged as medical masks. The export of non-medical masks to the United States does not fall within the scope of Announcement No. 5 of 2020, but companies should note that products must be registered with NIOSH before they can be marketed in the United States. Medical/non-medical masks exported to the EU and EU must be affixed with the CE mark, but the applicable standards are different. Medical masks belong to Class I devices in the EU, which are classified into Class I non-sterile and sterile. They need to be CE affixed in accordance with the EU Medical Device Directive 93/42/EEC (MDD) or EU Medical Device Regulation EU2017/745 (MDR) The mark, the corresponding standard is EN14683, and the masks exported to the European Union with the above content on the outer packaging or test reports or certificates can be judged as medical masks. It should be noted that according to the sterile/non-sterile status of the mask, the EU adopts different conformity assessment methods. Non-sterile medical copper mask companies only need to make a CE self-conformity declaration and do not need to pass the certification of the notified body. After preparing the corresponding documents and test reports, you can complete the declaration of conformity by yourself.
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